Nutrition Beverage Tolerance Study

NCT ID: NCT01464385

Last Updated: 2012-05-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

121 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-10-31

Study Completion Date

2011-12-31

Brief Summary

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To evaluate the sensations experienced by subjects consuming a nutritional beverage.

Detailed Description

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Conditions

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Human Volunteers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Nutritional Beverage #2

Nutritional Beverage with an amino acid Oral 237 ml

Group Type EXPERIMENTAL

Nutritional Beverage

Intervention Type OTHER

Nutritional Beverage Oral 237 mL

Nutritional Beverage #3

Nutritional Beverage with an amino acid Oral 237 ml

Group Type EXPERIMENTAL

Nutritional Beverage

Intervention Type OTHER

Nutritional Beverage Oral 237mL

Nutritional Beverage #1

Nutritional Beverage Oral 237 ml

Group Type PLACEBO_COMPARATOR

Nutritional Beverage

Intervention Type OTHER

Nutritional Beverage Oral 237mL

Interventions

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Nutritional Beverage

Nutritional Beverage Oral 237mL

Intervention Type OTHER

Nutritional Beverage

Nutritional Beverage Oral 237 mL

Intervention Type OTHER

Nutritional Beverage

Nutritional Beverage Oral 237mL

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

Subject ≥ 45 years of age.

If female, subject is either postmenopausal for at least 1 year or surgically sterile

Subject reports that he/she has not participated in a research study in the last three months.

Exclusion Criteria

Subject has active metabolic or endocrine disease

Subject has an autoimmune disorder

Subject has a disorder of gastrointestinal tract or any gastrointestinal surgery in past 12 months.

Subject has food allergy, celiac disease or intolerance to any of the ingredients in the study products

Subject reports history of parasthesia; and/or is currently taking medication/dietary supplements/substances that may cause parasthesia for 4 weeks prior to screening
Minimum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Abbott Nutrition

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Vikkie Mustad, PhD

Role: STUDY_CHAIR

Abbott

Locations

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The National Food Lab

Livermore, California, United States

Site Status

Countries

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United States

Other Identifiers

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BK98

Identifier Type: -

Identifier Source: org_study_id

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